title: Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT00629278).
abstract: Trastuzumab, a monoclonal antibody against the HER2 receptor, is currently approved as a part of adjuvant therapy for patients with HER2-overexpressing breast tumors. The Short-HER study is a phase III randomized, multicentric Italian trial aimed at testing the optimal duration of adjuvant trastuzumab. In this trial, 2500 patients with HER2-positive breast cancer will be randomized to receive the following: (arm A, long) 4 courses of anthracycline- based chemotherapy (doxorubicin/cyclophosphamide or epidoxorubicin/cyclophosphamide) followed by 4 courses of docetaxel or paclitaxel in combination with trastuzumab, followed by 14 additional courses of trastuzumab administered every 3 weeks (for a total of 18 3-weekly doses of trastuzumab); or (arm B, short) 3 courses of 3-weekly docetaxel in combination with weekly trastuzumab (for a total of 9 weekly doses of trastuzumab) followed by 3 courses of 5-fluorouracil/epirubicin/cyclophosphamide. The primary objective is disease-free survival.
authors.affiliation: Division of Medical Oncology, Department of Oncology and Hematology, University Hospital, Modena, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Guarneri
authors.forename: Antonio
authors.initials: A
authors.lastname: Frassoldati
authors.forename: Paolo
authors.initials: P
authors.lastname: Bruzzi
authors.forename: Roberto
authors.initials: R
authors.lastname: D'Amico
authors.forename: Maurizio
authors.initials: M
authors.lastname: Belfiglio
authors.forename: Annamaria
authors.initials: A
authors.lastname: Molino
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
authors.forename: Stefano
authors.initials: S
authors.lastname: Cascinu
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
authors.forename: Angelo
authors.initials: A
authors.lastname: Di Leo
authors.forename: Paolo
authors.initials: P
authors.lastname: Pronzato
authors.forename: Lucio
authors.initials: L
authors.lastname: Crinó
authors.forename: Biagio
authors.initials: B
authors.lastname: Agostara
authors.forename: PierFranco
authors.initials: P
authors.lastname: Conte
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012107:Research Design; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003520:Cyclophosphamide; D000077143:Docetaxel; D004317:Doxorubicin; D015251:Epirubicin; D005472:Fluorouracil; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human